Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Eliminating Monitor Overuse Trial (EMO Trial)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05132322
Recruitment Status : Recruiting
First Posted : November 24, 2021
Last Update Posted : January 20, 2022
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
University of Pennsylvania
Boston Children's Hospital
Children's Hospital Medical Center, Cincinnati
Pediatric Research in Inpatient Settings (PRIS) Network
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief Summary:
The purpose of this study is to identify the optimal deimplementation strategies for an overused practice: continuous pulse oximetry monitoring of children hospitalized with bronchiolitis who are not receiving supplemental oxygen.

Condition or disease Intervention/treatment Phase
Bronchiolitis Acute Viral Behavioral: Educational Outreach Behavioral: Audit & Feedback (unit level) Behavioral: Audit & Feedback (real time, individual-level) Behavioral: Clinical Pathway Integrated into Electronic Health Record Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Eliminating Monitor Overuse (EMO) Hybrid Effectiveness-Deimplementation Trial
Actual Study Start Date : December 1, 2021
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : August 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Unlearning Only
Includes educational outreach and audit & feedback.
Behavioral: Educational Outreach
Educational outreach includes staff-targeted educational materials and outreach sessions summarizing the current evidence and guideline recommendations for pulse oximetry use in bronchiolitis.

Behavioral: Audit & Feedback (unit level)
Weekly unit-level feedback of each hospital's guideline-concordant practice will be distributed to sites in the form of a visual dashboard that includes comparisons over time and between hospitals. The dashboard will then be shared locally on a weekly basis with clinicians in person and electronically.

Behavioral: Audit & Feedback (real time, individual-level)
Real-time feedback will occur at the individual clinician level. When collecting data on an individual patient, data collectors encountering guideline-discordant continuous monitoring are empowered to briefly ask any available clinician responsible for that patient's care, in a nonjudgmental way, about indications for monitoring that patient. The clinician is ultimately responsible for deciding if any changes are indicated.

Experimental: Unlearning + Substitution
Includes educational outreach, audit & feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry.
Behavioral: Educational Outreach
Educational outreach includes staff-targeted educational materials and outreach sessions summarizing the current evidence and guideline recommendations for pulse oximetry use in bronchiolitis.

Behavioral: Audit & Feedback (unit level)
Weekly unit-level feedback of each hospital's guideline-concordant practice will be distributed to sites in the form of a visual dashboard that includes comparisons over time and between hospitals. The dashboard will then be shared locally on a weekly basis with clinicians in person and electronically.

Behavioral: Audit & Feedback (real time, individual-level)
Real-time feedback will occur at the individual clinician level. When collecting data on an individual patient, data collectors encountering guideline-discordant continuous monitoring are empowered to briefly ask any available clinician responsible for that patient's care, in a nonjudgmental way, about indications for monitoring that patient. The clinician is ultimately responsible for deciding if any changes are indicated.

Behavioral: Clinical Pathway Integrated into Electronic Health Record
Clinical pathways guide clinicians step-by-step through evidence-based care. Based on the existing guidelines for physiologic monitoring in bronchiolitis, the pathway will clearly specify (a) situations when it is appropriate to initiate intermittent SpO2 measurement instead of continuous SpO2 monitoring, and (b) when it is appropriate to discontinue continuous SpO2 monitoring altogether, and transition to intermittent SpO2 measurement. In order to be visible to clinicians as they perform patient care, the pathway will be integrated into the electronic health record at sites randomized to this intervention.




Primary Outcome Measures :
  1. Sustainability of guideline-concordant deimplementation of continuous pulse oximetry monitoring [ Time Frame: 3 years ]
    Sustainability of guideline-concordant deimplementation of continuous pulse oximetry (SpO2) monitoring is the primary trial outcome. It is calculated based on penetration (outcome 2). Sustainability will be measured longitudinally based on calculating the differences in the penetration of guideline-concordant practice at baseline, compared to the penetration during the sustainability phase.


Secondary Outcome Measures :
  1. Penetration [ Time Frame: Up to 4 years ]
    Penetration is calculated as the percentage of bronchiolitis patients who are in room air (not receiving any supplemental oxygen) and are receiving guideline-concordant care (this means they are not being continuously SpO2-monitored). The continuous monitoring status is determined using direct observation on hospital units.

  2. Acceptability of deimplementation [ Time Frame: Up to 3 years ]
    Acceptability of deimplementation among staff measured by questionnaire. Items are adapted from the validated Acceptability of Implementation Measure (AIM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better acceptability. The items are analyzed individually and not summed to a total score.

  3. Feasibility of deimplementation [ Time Frame: Up to 3 years ]
    Feasibility of deimplementation among staff measured by questionnaire. Items are adapted from the validated Feasibility of Implementation Measure (FIM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better feasibility. The items are analyzed individually and not summed to a total score.

  4. Appropriateness of deimplementation [ Time Frame: Up to 3 years ]
    Appropriateness of deimplementation among staff measured by questionnaire. Items are adapted from the validated Implementation Appropriateness Measure (IAM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better appropriateness. The items are analyzed individually and not summed to a total score.

  5. Perceived safety of deimplementation [ Time Frame: Up to 3 years ]
    Perceived safety of deimplementation among staff measured by questionnaire. Items are adapted from those used in the pilot study preceding this trial and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better agreement with each question.

  6. Cost of deimplementation strategies [ Time Frame: Up to 3 years ]
    Cost of delivering each of the strategies will be assessed using a pragmatic Time-Driven Activity Based Costing method developed specifically for economic analysis of implementation strategies.

  7. Length of Hospital Stay [ Time Frame: Up to 4 years ]
    The length of hospital stay is the duration of time that elapses between the time a patient is admitted with bronchiolitis to an inpatient unit of the hospital until the time they are discharged from the hospital, using data manually abstracted from the electronic health record chart.

  8. Duration of Oxygen Supplementation [ Time Frame: Up to 4 years ]
    The oxygen supplementation duration is the total duration of time during which a patient is documented as receiving supplemental oxygen during hospitalization.


Other Outcome Measures:
  1. Exploratory long-term sustainability [ Time Frame: 4 years ]

    Exploratory long-term sustainability is calculated based on penetration. Penetration is the percentage of bronchiolitis patients who are in room air (not receiving any supplemental oxygen) and are receiving guideline-concordant care (this means they are not being continuously SpO2-monitored). The continuous monitoring status is determined using direct observation on hospital units.

    In this exploratory outcome investigators are using an alternative definition of sustainability in which, in order to meet criteria for having successfully sustained a practice change, hospitals must first (a) experience a significant increase in penetration between baseline and active deimplementation, and then (b) maintain the increased penetration at ≥90% of the active deimplementation phase level through the end of the sustainability period.


  2. Routinization of guideline-concordant deimplementation [ Time Frame: Up to 3 years ]
    Routinization is a dimension of the Slaghuis Measurement Instrument for Sustainability of Work Practices. Routinization is the process in which clinicians develop new routines such that the intended practice changes become part of their everyday work.

  3. Institutionalization of guideline-concordant deimplementation [ Time Frame: Up to 3 years ]
    Institutionalization is a dimension of the Slaghuis Measurement Instrument for Sustainability of Work Practices. Institutionalization is the process in which the organization embeds the intended practice change into its existing systems and structures.

  4. Implementation Climate [ Time Frame: Up to 3 years ]
    Implementation Climate is whether the environment expects, supports, and rewards deimplementation of continuous SpO2 monitoring. Investigators will measure Implementation Climate using items from the Implementation Climate Scale. This is an 18-item scale with each item having 5 response options from 0 through 4. Higher total scores indicate better implementation climate.

  5. Implementation Leadership [ Time Frame: Up to 3 years ]
    Implementation Leadership is leader behaviors that include being proactive, knowledgeable, supportive, and persevering around deimplementation of continuous SpO2 monitoring. Implementation Leadership will be measured using items from the Implementation Leadership Scale. This is a 12-item scale with each item having 5 response options from 0 through 4. Higher total scores indicate better implementation leadership.

  6. Psychological reactance [ Time Frame: Up to 3 years ]
    Assessment of psychological reactance by questionnaire will be performed using validated items from seminal research in psychological reactance in health communication. This includes dimensions of freedom threat, emotional response, and cognitive response to deimplementation. Items are rated on 5-point Likert scales ranging from 0 through 4 with higher scores indicating more reactance for some items, and less reactance on other items. The items are analyzed individually and not summed to a total score.

  7. Underuse of Pulse Oximetry Monitoring in High Risk Patients [ Time Frame: Up to 4 years ]

    Underuse is defined as failing to continuously SpO2 -monitor bronchiolitis patients receiving

    ≥2L/min supplemental oxygen (a marker of more severe disease). It is calculated as the percentage of bronchiolitis patients who are receiving ≥2L/min supplemental oxygen, and are not being continuously SpO2-monitored. It is measured using direct observation.


  8. Number of Bronchiolitis Patients with Emergency Hypoxemic Events [ Time Frame: Up to 4 years ]
    Investigators will collect data on emergency events occurring in bronchiolitis patients as a potential unintended consequence of deimplementation efforts. Investigators will identify code blue and rapid response team activations in bronchiolitis patients who were unmonitored at the time of the event and were subsequently found to be hypoxemic to <85% at the time of the event when SpO2 monitors were applied. These outcomes will be extracted from local patient safety databases (e.g., local rapid response team activation logs).

  9. Number of Bronchiolitis Patients with Readmissions Featuring Hypoxemia Upon Re-Presentation [ Time Frame: Up to 4 years ]
    Investigators will collect data on readmissions occurring in bronchiolitis patients as a potential unintended consequence of deimplementation efforts. Investigators will identify readmissions of bronchiolitis patients to the hospital within 7 days of discharge who were found to be hypoxemic to <85% upon re-presentation to the emergency department.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Population 1a: Hospital staff who complete study questionnaires.

Inclusion Criteria:

  • Nurse or physician fluent in English and employed full-time by the hospital, affiliated practice, or affiliated university who cared for bronchiolitis patients on a unit participating in the trial during at least 5 days of the most recent bronchiolitis season
  • Hospital administrator fluent in English who oversaw the care of bronchiolitis on a local level (e.g. nurse manager) or a hospital level (e.g. Chief Quality and Safety Officer)

Exclusion Criteria:

• Under the direct supervision of study or site principal investigator(s)

Population 1b: Hospital staff who participate in qualitative interviews

Inclusion Criteria:

• Nurse or physician fluent in English and employed full-time by the hospital, affiliated practice, or affiliated university who cared for bronchiolitis patients on a unit participating in the trial during at least 5 days of the most recent bronchiolitis season

Exclusion Criteria:

• Under the direct supervision of study or site principal investigator(s)

Population 2a: Bronchiolitis patients directly observed while not receiving supplemental oxygen ("in room air," for primary trial outcome)

Inclusion Criteria:

  • Infants and children 2 months through 23 months old
  • Hospitalized on non-ICU wards participating in the trial
  • Cared for by generalist inpatient services (e.g. general pediatrics, hospital medicine)
  • Primary diagnosis of bronchiolitis in most recent physician progress note
  • Not actively receiving supplemental oxygen ("in room air")
  • Last documented receipt of supplemental oxygen >1 hour prior to direct observational data collection

Exclusion Criteria:

  • Documented apnea or cyanosis during the current illness
  • Extreme prematurity (<28 weeks completed gestation)
  • Cardiac disease
  • Pulmonary hypertension
  • Chronic lung disease
  • Home oxygen requirement
  • Neuromuscular disease
  • Immunodeficiency
  • Cancer
  • Severe Acute Respiratory Syndrome Coronavirus 2 (Covid-19 / SARS-CoV-2)-related illness (known or suspected, including multisystem inflammatory syndrome in children multi-system inflammatory syndrome in children (MIS-C)

Population 2b: Bronchiolitis patients directly observed while receiving supplemental oxygen (for underuse evaluation).

Inclusion Criteria:

  • Infants and children 2 months through 23 months old
  • Hospitalized on non-ICU wards participating in the trial
  • Cared for by generalist inpatient services (e.g. general pediatrics, hospital medicine)
  • Primary diagnosis of bronchiolitis in most recent physician progress note
  • Actively receiving ≥2 Liters/minute (2L/min) supplemental oxygen or 21% room air flow

Exclusion Criteria:

  • Extreme prematurity (<28 weeks completed gestation)
  • Cardiac disease
  • Pulmonary hypertension
  • Chronic lung disease
  • Home oxygen requirement
  • Neuromuscular disease
  • Immunodeficiency
  • Cancer
  • Severe Acute Respiratory Syndrome Coronavirus 2 [Covid-19 / SARS-CoV-2 (known or suspected)]

Population 3: Parents or guardians of bronchiolitis patients who participate in qualitative interviews.

Inclusion Criteria:

  • Their child was hospitalized for bronchiolitis on a unit participating in the trial during the most recent bronchiolitis season
  • Their child was found to be continuously SpO2-monitored while in room air during Aim 1 data collection
  • Fluent in English

Exclusion criteria:

  • Does not recall being present while child was continuously SpO2-monitored
  • They are an employee of the hospital or a hospital volunteer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05132322


Contacts
Layout table for location contacts
Contact: Christopher P Bonafide, MD, MSCE 267-426-2901 bonafide@chop.edu
Contact: Canita Brent, MPH emostudy@chop.edu

Locations
Show Show 56 study locations
Sponsors and Collaborators
Children's Hospital of Philadelphia
National Heart, Lung, and Blood Institute (NHLBI)
University of Pennsylvania
Boston Children's Hospital
Children's Hospital Medical Center, Cincinnati
Pediatric Research in Inpatient Settings (PRIS) Network
Investigators
Layout table for investigator information
Principal Investigator: Christopher P Bonafide, MD, MSCE Children's Hospital of Philadelphia
Principal Investigator: Rinad S Beidas, PhD University of Pennsylvania
Layout table for additonal information
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT05132322    
Other Study ID Numbers: 21-018560
U01HL159880 ( U.S. NIH Grant/Contract )
First Posted: November 24, 2021    Key Record Dates
Last Update Posted: January 20, 2022
Last Verified: January 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Philadelphia:
pulse oximetry
deimplementation
cluster-randomized trial
effectiveness-implementation hybrid trial
implementation science
Additional relevant MeSH terms:
Layout table for MeSH terms
Bronchiolitis
Bronchitis
Respiratory Tract Infections
Infections
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases